Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

NCT03340818 | Completed

• 1 other identifier: BMC-1788
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.

Conditions

Discogenic Pain

Keywords

Low back pain, bone marrow concentrate, disc degeneration

Outcome Measures

Primary Outcomes (2)

• Pain relief treatment vs placebo group 50%

  Pain reduction of at least 50% at 6 months post-procedure using Visual Analog Scale (VAS) as indicators of pain relief. A reduction in the VAS of at least 50% from baseline is considered successful. VAS of 10 is considered "worst pain imaginable" and VAS of 0 is no pain at all.

  6 months

• Functional improvement vs Placebo group 50%

  Functional improvement of at least 50% at 6 months post-procedure using the Oswestry Disability Index (ODI). A reduction of at least 50% in the Oswestry Disability Index is considered successful. The lower the ODI score, the less impact the pain has on a patients daily functioning.

  6 months

Secondary Outcomes (4)

• Pain relief treatment vs placebo group 50%

  3 months, 12 months

• Pain relief treatment vs placebo 30%

  3, 6, 12 months

• Functional improvement treatment vs placebo 50%

  3 months, 12 months

• Functional improvement treatment vs placebo 30%

  3 months, 12 months

Other Outcomes (2)

• Medication usage

  12 months

• Adjunct therapy

  12 months

Study Arms (2)

Bone Marrow Concentrate

EXPERIMENTAL

Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.

Other: Bone Marrow Concentrate

Placebo Group

SHAM COMPARATOR

Patients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients.

Other: Placebo

Interventions

Bone Marrow Concentrate OTHER

Bone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance

Bone Marrow Concentrate

Placebo OTHER

Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
• Average pain of at lest 40/100 on VAS pre-procedure.
• Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
• Advanced imaging of MRI or CT demonstrating abnormal disc pathology
• Having provided informed consent

You may not qualify if:

• Active moderate to severe lumbar radiculopathy
• Negative discogram
• Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
• Active infection
• Moderate to severe anemia, thrombocytopenia or leukopenia
• Spinal fracture within the past 6 months
• Severe psychological illness
• Inability to consent to the procedure due to cognitive issues
• Prior surgery at a level considered to be the source of pain
• Lumbar surgery within the past 6 months
• Women who are pregnant or breast feeding
• Prior intradiscal therapeutic injection or procedure
• Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
• Inflammatory arthritis
• Any cancer within the past 5 years, except basal cell or squamous cell skin cancer

Sponsors & Collaborators

• APM Spine and Sports Physicians: lead

Study Sites (1)

Jordan Young Institute

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• David S Levi, MD

  Jordan Young Institute

  PRINCIPAL INVESTIGATOR

• Scott I Horn, DO

  Jordan Young Institute

  STUDY CHAIR

• Josh Levin, MD

  Stanford University

  STUDY CHAIR

• Sara A Tyszko, PA-C

  Jordan Young Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and PA providing follow up care and assessing data from ODI, VAS etc will be blinded. Physician performing procedure will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind placebo controlled

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 14, 2017
• Study Start: August 1, 2018
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: August 7, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)